Pre-emptive Analgesia With Qutenza in Lower Limb Amputation
Information source: NHS Greater Glasgow and Clyde
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain; Lower Limb Amputation
Intervention: Qutenza (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: NHS Greater Glasgow and Clyde Official(s) and/or principal investigator(s):
Emma L Aitken, MBChB, Principal Investigator, Affiliation: NHS Greater Glasgow and Clyde
Overall contact:
Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net
Summary
Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of
patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit
protheses and mobilise. Current treatment options are limited and existing painkillers have
significant side effects. Nevertheless there is some evidence that pre-emptive analgesia
(pain relief provided prior to the surgery) has additional benefits after the surgery
(Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is
applied directly onto the skin. It works by desensitising to pain receptors in the skin
(Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in
other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for
pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot,
randomised controlled study of 30 patients undergoing lower limb amputation who will have
Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks
post-operatively with regular assessment of pain scores, quality of life and wound healing.
Clinical Details
Official title: The Role of Pre-emptive Analgesia With Qutenza (Topical Capsaicin 8%) in Preventing Neuropathic Pain Following Lower Limb Amputation: a Pilot Randomised Controlled Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Chronic neuropathic pain
Secondary outcome: Neuropathic painAcute post-operative pain Wound healing Quality of life Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All adult patients >18 years old undergoing lower limb amputation
Exclusion Criteria:
Traumatic amputation Severe active sepsis in non-viable limb Illness necessitating urgent
surgery <24 hours after admission to hospital Hypersensitivity to Qutenza, Emla or any of
the excipients Broken skin or active ulceration at the site of application Severe
uncontrolled hypertension (systolic BP >200) Proven cardiac event during the preceding 3
months Women who are pregnant or breast feeding Lack of capacity or inability to provide
informed consent Declines participation in the study
Locations and Contacts
Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net
Western Infirmary, Glasgow, Lanarkshire G116NY, United Kingdom; Not yet recruiting
Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net
David B Kingsmore, MBChB MD, Phone: 01412111750, Email: david.kingsmore@ggc.scot.nhs.uk
Emma L Aitken, MBChB, Principal Investigator
Additional Information
Starting date: February 2013
Last updated: December 10, 2012
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